MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE PRO BEDWETTING ALARM

Device Problem Battery Problem (2885)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 01/23/2018

Event Type  Injury  

Event Description

I purchased the malem bedwetting alarm from the bedwetting store.It first got a little hot when we first inserted batteries and tested the alarm.We ignored this thinking it was normal.A few hours into the night and my son yelled, we noticed that the product got super hot.We threw the alarm, but not until my son had suffered burns on his neck.His neck was red and covered with multiple burn blisters.We applied ice, however later had to rush him to the hospital for treatment.With several complaints online about this same exact thing, i look forward to the fda taking action against this seller soon.(b)(6).

• Brand Name: MALEM ULTIMATE PRO BEDWETTING ALARM
• Type of Device: MALEM ULTIMATE PRO BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7233662
• MDR Text Key: 98847485
• Report Number: MW5074990
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR